Apparatus and method for everting catheter for embryo transfer using transvaginal ultrasound

ABSTRACT

Everting balloon systems and methods for using the same with an alignment element for stability and anti-rotation of the everting balloon are disclosed herein. The systems can be configured to access and deliver instruments, media, or other catheters into bodily lumens and cavities. The alignment element can eliminate the potential for the everting membrane to become twisted or rotated which could impact access or the ability of the system to deliver materials. A compliance member can facilitate internal pressurization of the everting catheter system. An everting catheter system can be configured for use with transvaginal ultrasound and a lower profile speculum is described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Patent ApplicationNo. PCT/US2018/065046 filed Dec. 11, 2018, which claims priority to U.S.Provisional Application No. 62/597,353 filed Dec. 11, 2017, which areincorporated by reference herein in their entireties.

BACKGROUND

This disclosure can be used for everting catheters that can have aninner catheter, outer catheter, and everting membrane that can beconnected to both catheters. The inner catheter may contain an innerlumen to pass fluid or media, drugs or therapeutic agents, instrumentsor devices, and other catheters.

For physicians and medical professionals, accessing systems for vesselsand bodily cavities in patients have typically used various guidewireand catheter technologies or everting catheters. Everting cathetersutilize a traversing action in which a balloon is inverted and with theinfluence of hydraulic pressure created by a compressible orincompressible fluid or media, rolls inside out or everts with apropulsion force through the vessel. Everting balloons have beenreferred to as rolling or outrolling balloons, evaginating membranes,toposcopic catheters, or linear everting catheters such as those in U.S.Pat. Nos. 5,364,345; 5,372,247; 5,458,573; 5,472,419; 5,630,797;5,902,286; 5,993,427; 6,039,721; 3,421,509; and 3,911,927; all of whichare incorporated herein by reference in their entireties. These arecategorized as everting balloons and are for traversing vessels,cavities, tubes, or ducts in a frictionless manner. In other words, aneverting balloon can traverse a tube without imparting any shear forceson the wall being traversed. Because of this action and lack of shearforces, resultant trauma can be reduced and the risk of perforationreduced. In addition as a result of the mechanism of travel through avessel, material and substances in the proximal portion of the tube orvessel are not pushed or advanced forward to a more distal portion ofthe tube or vessel.

In addition, as the everting catheter deploys inside out, uncontaminatedor untouched balloon material is placed inside the vessel wall. In theinverted or undeployed state, the balloon is housed inside the catheterbody and cannot come into contact with the patient or physician. As theballoon is pressurized and everted, the balloon material rolls insideout without contacting any element outside of the vessel. Anotheradvantage of an everting balloon catheter is that the method of accessis more comfortable for the patient since the hydraulic forces “pull”the balloon membrane through the vessel or duct as opposed to a standardcatheter that needs to be “pushed” into and through the vessel or duct.

Everting catheters have been described as dilatation catheters.Representative examples of dilating everting catheters include U.S. Pat.Nos. 5,364,345 and 4,863,440, both of which are incorporated byreference herein in their entireties.

Everting catheters have also been described with additional elementssuch as a handle for controlling instruments within an evertingcatheter. A representative example is U.S. Pat. No. 5,346,498 which isincorporated by reference herein in its entirety. Everting ballooncatheters can be constructed with an inner catheter with an internallumen or through-lumen (or thru-lumen). The through-lumen can be usedfor the passage of instruments, media, materials, therapeutic agents,endoscope, guidewires, or other instruments. Representative samples ofeverting catheters with through-lumens are in U.S. Pat. Nos. 5,374,247and 5,458,573. In addition, everting catheters have been described withwaists or a narrowing of the balloon diameter, such as in U.S. Pat. No.5,074,845, which is incorporated by reference herein in its entirety.

Furthermore, infertility is a condition that affects 1 out of 8 couplesin the US. One of the early treatments in the infertility regime isinsemination. Intrauterine insemination or IUI is a very commonprocedure since it is in the early work up of an infertile couple. Mostassisted reproductive clinics perform at least 3 IUI cycles beforetrying more expensive treatment options such as IVF.

Also, when delivering the reproductive material, such as an embryo, intothe uterine cavity, vacuum effect can unintentionally remove thereproductive material from the uterine cavity. In existing systems, whenthe transfer catheter is retracted from a second outer or guidingcatheter (e.g., the “inner” catheter), the retraction produces vacuumpressure within the uterine cavity. This vacuum pressure is created inthe uterine cavity by the removal and backward movement of the transfercatheter within the inner catheter. After the embryo transfer iscompleted, an embryologist may inspect the transfer catheter to verifythat the embryos or reproductive material was indeed deposited in theuterus and not pulled back into the transfer catheter because of thevacuum effect. The same procedure may be done for the outer catheteronce this catheter is removed.

The passage of the embryo transfer catheter may become impeded if theeverting membrane is rotated or twisted. Twists within the balloonmembrane can also reduce the ability of the everting membrane totraverse a lumen or cavity or unroll as intended. A twist in the balloonmembrane can occur if the inner catheter is rotated about its centralaxis in relation to a stationary outer catheter. By rotating the innercatheter, the balloon membrane which is connected between both the outercatheter and inner catheter becomes twisted. In this particularsituation of an everting balloon, twists in the balloon membrane cansignificantly impact performance of the everting system.

A twist in the everting membrane can occur during use or prep of thecatheter prior to inserting the device within a patient. A twist in theeverting membrane can also occur when a catheter system has therequirement of multiple eversions and retractions to complete aprocedure within a patient. Likewise, a twist in the balloon system canunintentionally occur as a byproduct of the manufacturing process.

In the device configuration using a handle system, an anti-rotationfeature can be particularly advantageous. As described previously,handles are very useful for driving the inner catheter and controllingthe advancement and retraction of instruments, other catheters, media,and materials within the inner catheter lumen. Manipulation of a handlecan inadvertently rotate the inner catheter system within the outercatheter and thereby creates twists in the balloon membrane. Thissituation can be exasperated by the introduction and removal of multipleinstruments and devices within the inner catheter lumen.

Having an everting catheter system in which twists or inadvertentrotations of the balloon membrane will enable more stable and secure useof an everting catheter. An untwisted balloon membrane provides theleast obstructed passage within the everting system. Some evertingcatheter systems will be more prone to balloon twisting due to thelength of the balloon membrane and inner catheter and type of balloonmembrane material. In some clinical applications, more tortuous anatomymay instigate a greater likelihood of balloon twists as a result of themanipulations the clinician may need to perform to complete theprocedure or obtain access to the desired target location in the body.

Maintaining the alignment of the inner catheter, outer catheter, andballoon membrane may be accomplished through a handle and ratchet systemas described previously. The alignment feature is accomplished by theratchet and handle that prevents rotation of the inner catheter. Thesystems described herein are directed towards internal catheterapparatus that provide alignment or anti-rotation capability withoutrequiring an additional set of components like rails, tracks, ratchets,or handles on the exterior for the catheter system.

Another clinical issue with an everting catheter is that physicians mayinadvertently pull or elongate the inner catheter upon inversion of theballoon membrane. Over-elongation can stretch the balloon membrane ordamage the catheter components. A feature that mechanically preventsthis from occurring will be a benefit to the catheter system.

Another problematic issue for everting catheters is the pressurizationstep in prepping the catheter. One option that is described in the priorart is the use of an inflation device with pressure gauge that indicatesthe internal pressure of the catheter system. Inflation devices withpressure gauges, or building an integral pressure gauge within thecatheter system, can be expensive. Using a separate, reusable pressuregauge adds to the number of components required for performing theprocedure. Having a simple mechanism that regulates and indicates theamount of pressure within the catheter system would be a benefit. Formore specialized procedures, being able to modulate the internalpressure depending upon the medical procedure could be particularlyadvantageous.

For everting catheters used in IVF procedures, it is beneficial tostabilize the inner catheter when full eversion is completed fortwo-stage embryo transfer procedures. A two-stage embryo transfer isperformed by everting the membrane across the endocervical canal andinto the uterine cavity and subsequently placing the loaded embryotransfer catheter through the inner catheter and ultimately within theuterus. This operation is done in two steps and the infertilityspecialist will inform the embryologist that the inner catheter has beeneverted and is now in place within the uterine cavity. The embryologistwill then aspirate and load the embryo or embryos into the distal end ofthe embryo transfer catheter for eventual insertion through the innercatheter for deposition in to the uterine cavity. This is the completionof the second stage of the process. During the loading step performed bythe embryologist, a mechanism that stabilizes and indicates to the userthat the inner catheter is in position would be a benefit.

Another problem with everting catheters is preparing the system byinternal pressurization. This preparation step can vary among users andover-pressurization, and under-pressurization, of the everting systemcan negatively impact the performance of the device.

Accessories can be used by the embryologist and physician performing thetransfer procedure to handle the embryo transfer catheter.

The embryo transfer procedure can be done with transvaginal ultrasound(TUS). In current medical practice, the significant majority of IVFprocedures are performed using abdominal ultrasound over TUS, or noultrasound visualization at all. TUS in most practitioners' handsprovides greater or enhanced visibility of the IVF catheters andprocedure in general than abdominal ultrasound since the ultrasoundtransducer is closer in physical proximity to the catheters or uterus(the visualization target) in situ. Secondly, abdominal ultrasound mayneed to penetrate through varying amounts or layers of adipose or fattissue. To overcome this situation in more obese women, the ultrasoundtechnician needs to push the abdominal probe deeply into the tissue ofthe female patient's stomach to obtain sufficient views which can beuncomfortable or painful for the patient. Thirdly, to facilitate thevisualization of the catheters in the uterine cavity, women areinstructed prior to the procedure to maintain a full bladder for theentire procedure. In some cases if the visualization is not sufficient,female patients are asked to consume more fluids and the procedure isdelayed to allow for time for urine to be created, instilled, andvisible in the bladder. And finally, abdominal ultrasound requires anultrasound technician, nurse, physician, or additional pair of hands tomanipulate the abdominal ultrasound during the actual IVF procedure. Insome situations the IVF physician will need to obtain the abdominalultrasound image and then pass off or release the abdominal ultrasoundprobe to the technician, nurse, or other physician so that the IVFcatheterization procedure can be performed. As such, for all of thereasons mentioned above, the ability to perform IVF procedures moreeasily using TUS would be a benefit to patients and physicians. Anotherarea to facilitate IVF procedures would be to allow the physician to useboth instruments without requiring or necessitating an additional pairof hands to complete the procedure. This is particularly true with TUSsince it would enhance the procedure if the physician manipulating thecatheters, and directing the ultrasound imaging, was the same physician.Having a mechanism that allows the physician performing IVF with TUS tocouple the everting catheter, or IVF catheter in general, to the TUSprobe so that the contralateral hand of the physician could advance theembryo transfer catheter would be advantageous.

Another area of improvement would be to automate the translation and/orretraction of the inner catheter without requiring the physician to usetwo hands to complete the movements. A manual controller that isoperated by one hand can be coupled to the everting catheter system or amechanism that automatically translates and/or retracts the innercatheter.

Another area of improvement for IVF and uterine procedures in generalwould be a modified type of speculum that is more comfortable for thepatient. This is particularly true for IVF procedures since it has beenreported in medical literature that the act of placing a speculum in apatient by itself create the nidus for uterine contractions. For IVF,the ability to perform the procedure with a specific speculum that iseasily adjustable for directed viewing of the exocervix, can be directedfor specific lateral wall viewing, can become low profile for theinsertion of other devices like TUS probe, and facilitates the use of aneverting IVF catheter, or any IVF catheter in general, would be abenefit. This specific speculum can work as a system with the IVFcatheter or any intravaginal or transvaginal procedure separatelywithout an everting catheter or catheters in general and instead wouldprovide a lower profile speculum for visualizing the vagina.

SUMMARY

An everting balloon system is disclosed that can be used for uterineaccess procedures. The everting balloon system can be used for IVF andintrauterine insemination procedures, urinary incontinence diagnosticand therapeutic procedures, delivering intra-fallopian tube inserts,media, or diagnostic instruments, dilation of a body lumen, for accessand sealing within a body cavity, or combinations thereof. The systemcan have a handle for insertion. The everting catheter system can beused for TUS IVF procedures. The everting catheter system can havemechanisms that automatically translate and/or retract the innercatheter which is coupled to the everting membrane. A speculum can beused with everting catheters and other transvaginal catheter procedures.

The everting balloon system can be used to access the uterus, bladder,ureters, kidneys, ducts, vessels of the vasculature, nasal passageways,other bodily lumens, or combinations thereof. Devices, tools,instrumentation, endoscopes, drugs, therapeutic agents, sampling devices(brushes, biopsy, and aspiration mechanisms), or combinations thereofcan be delivered through the inner catheter lumen to the target site.

The everting balloon system can have an internal alignment mechanismthat prevents rotation and spinning of the balloon membrane.

The everting balloon system can have an internal mechanism that preventsover-elongation of the inner catheter during balloon inversion.

The everting balloon system can have a compliant pressurizationapparatus that's provides a pre-determined pressure within the cathetersystem with an indicator to the user that system is at the appropriateoperating pressure.

Another embodiment can automatically pressurize the everting balloonsystem to a predetermined amount.

The everting balloon system can have an integral pressurization systemthat provides an indicator and the ability to quickly shift thepressurization state of the balloon system from pressurized tonon-pressurized. Intermediate degrees of pressurization can also beselected.

The everting balloon system can have a mechanism that stabilizes theinner catheter at the full eversion stage and provides an indicator tothe user that catheter system is at the appropriate step in the processfor embryo transfer.

The everting balloon system can have a proximal hub connector that aidsthe physician and embryologist in delivering the embryo transfercatheter to the delivery catheter.

The everting balloon system can be shaped with distal end features thatfacilitate uterine access without the need for a speculum and/ortenaculum.

The everting catheter system can have accessories that make the handlingof the embryo transfer catheter easier.

The everting catheter system can be coupled to the TUS probe to allowfor simultaneous ultrasound visualization of the catheterizationprocedure in situ and manipulation of the catheters.

The everting catheter system can have mechanisms that automaticallytranslate and/or retract the inner catheter coupled to the evertingmembrane.

The everting catheter system that can couple to a speculum thatfacilitates handling of the catheter system in the vagina. The speculumitself can be used with or without the everting catheter system forother transvaginal procedures.

The everting catheter system can have controllers for both the innercatheter coupled to the everting membrane and a controller for theembryo transfer catheter, or the same controller can perform bothfunctions.

The everting catheter system can have an acorn tip at the distal endthat can be malleable or articulate to enter into the exocervical os.The acorn tip can also be detachable or retractable to reveal apenetrating tip to further guide the everting membrane into theexocervical os.

The TUS IVF procedure can have a specific speculum which provides astable platform for the physician to hold and position the IVF cathetersor devices.

The IVF procedures can use an everting catheter, a handle mechanism canbe incorporated that can allow for one-handed advancement or translationof both the inner catheter coupled to the everting balloon, and theadvancement of the embryo transfer catheter. Such a system can allow thephysician to maintain control of the TUS at all times for both theadvancement of the everting balloon catheter and the advancement of theembryo transfer catheter.

The distal end of the everting catheter which engages the exocervix canbe a distal tip acorn tip that articulates or can be malleable to bedirected towards the exocervix os or opening. A detachable orretractable acorn tip that exposes a more guiding or penetrating distalnozzle of the outer catheter that facilitates entry into the cervix canbe used.

The embryo transfer procedures can be performed with transvaginalultrasound. The disclosed systems and methods can be used and performedwithout a speculum, for example, for patient comfort.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A through 1E are longitudinal cross-sectional views of the distalend of a variation of a method for using the everting balloon system.

FIG. 2A illustrates an everting balloon system with a delivery catheter,embryo transfer catheter, and a pressurization syringe.

FIG. 2B illustrates a variation of the everting balloon system in afully everted configuration.

FIG. 2C illustrates an embryo transfer catheter beyond the distal end ofthe everting balloon membrane.

FIG. 3A illustrates a cross-sectional view of a flexible tip guidancewire beyond the distal end of the everting balloon membrane during theeversion process directing the everting balloon system beyond acul-de-sac in the endocervical canal.

FIG. 3B illustrates a cross-sectional view of a flexible tip guidancewire beyond the distal end of the everting balloon membrane at thecompletion of the eversion process beyond a cul-de-sac in theendocervical canal.

FIG. 4 illustrates a variation of the everting balloon system with analternative stopcock configuration for maintaining pressurization.

FIG. 5A illustrates a variation of the everting balloon system with aninternal alignment mechanism that prevents rotation and spinning of theballoon membrane.

FIG. 5B illustrates a cross-sectional axial view of the internalalignment mechanism and mating geometry of the delivery catheter tubing.

FIG. 5C illustrates another embodiment of the alignment piece.

FIG. 6 illustrates a variation of an everting balloon system with aninternal mechanism that prevents over-elongation of the inner catheterduring balloon inversion.

FIGS. 7A, 7B and 7C illustrate everting balloon systems with a compliantpressurization apparatus that's provides a pre-determined pressurewithin the catheter system with an indicator to the user that system isat the appropriate operating pressure.

FIG. 8 illustrates another embodiment of an everting balloon system witha mechanism that automatically pressurizes the everting balloon systemto a predetermined amount.

FIG. 9A illustrates an everting balloon system with an integralpressurization system that provides an indicator and the ability toquickly shift the pressurization state of the balloon system frompressurized to non-pressurized at the fully everted state of theeverting balloon system.

FIG. 9B illustrates an everting balloon system with an integralpressurization system that provides an indicator and the ability toquickly shift the pressurization state of the balloon system from highpressurization to low pressurization, and back to high pressurization,or multiple intermediate states of pressurization, during the eversionprocess.

FIG. 10 illustrates an everting balloon system with a mechanism thatstabilizes the inner catheter at the full eversion stage and provides anindicator to the user that catheter system is at the appropriate step inthe process for embryo transfer.

FIG. 11 illustrates an everting balloon system with a proximal hubconnector that aids the physician and embryologist in delivering theembryo transfer catheter to the delivery catheter.

FIGS. 12A and 12A′ illustrate a side view, and a perspective view whilein the grasp of a hand, respectively, of an everting balloon systemshaped with distal end features that facilitate uterine access withoutthe need for a speculum.

FIG. 12B illustrates in an end-on axial view of a variation of the acorntip and distal end features that facilitate uterine access without theneed for a speculum.

FIG. 13 illustrates in a side view of an everting balloon system with ahandle that controls the translation of the inner catheter.

FIGS. 14A and 14A′ illustrate side views of variations of the evertingcatheter balloon system that can have a translatable and adjustabledistal end tip that can alter the working length of the evertingballoon.

FIGS. 14B and 14B′ illustrate a variations of the translatable andadjustable distal end tip at an extended position with resultant workinglength of the everting balloon.

FIGS. 15A and 15A′ illustrate a protective tube system for the embryotransfer catheter that facilitates handling and transport of thecatheter.

FIGS. 15B, 15B′, and 15B″ illustrate a protective tube system for theembryo transfer catheter in the detached configuration for the loadingof embryos.

FIG. 15C illustrates a protective tube system for the embryo transfercatheter in the re-attached mode for the transport of the embryotransfer catheter.

FIG. 16 illustrates an everting catheter system that has a couplingelement to attach to the TUS probe.

FIG. 17A illustrates an everting catheter system with a spring loadedinner catheter for automatically translating the inner catheter.

FIGS. 17B, 17B′, and 17B″ illustrate a variation of an everting cathetersystem with a spring loaded inner catheter for automatically translatingthe inner catheter.

FIGS. 17C , 17C′, and 17C″ illustrate a variation of an evertingcatheter system with a spring loaded inner catheter for automaticallytranslating and retracting the inner catheter.

FIG. 17D illustrates an everting catheter system with a motor coupled tothe inner catheter for automatically translating and retracting theinner catheter.

FIGS. 18A through 18E illustrate variations of speculums that are notthe invention. FIG. 18B illustrates a speculum in use.

FIGS. 19A, 19A′ and 19B illustrate variations of the speculum.

FIGS. 19C and 19D illustrate variations of the speculum during use withthe TUS probe.

FIGS. 20 and 20′ are side and axial views, respectively, of a variationof the speculum coupled to the everting catheter system.

FIG. 21 illustrates an acorn tip at the distal end of an evertingcatheter that can be malleable.

FIG. 21′ illustrates an acorn tip at the distal end of an evertingcatheter that can be articulatable.

FIG. 22A is a cross-sectional view of a variation of the distal end ofan everting catheter that has an acorn tip that is detachable.

FIG. 22A′ is a cross-sectional view of the variation of the distal endof an everting catheter of FIG. 22A with the acorn tip removed to reveala penetrating member for insertion into the exocervical os.

FIG. 22B is a cross-sectional view of a variation of the distal end ofan everting catheter that has a retractable acorn tip.

FIG. 22B′ is a cross-sectional view of the variation of the distal endof an everting catheter of FIG. 22B with the acorn tip retracted toreveal a penetrating member for insertion into the exocervical os.

FIGS. 23 and 23′ illustrate a variation of the everting catheter systemhaving a controller that can advance and retract both the inner catheterand the embryo transfer catheter.

DETAILED DESCRIPTION

An everting balloon system 8 (also referred to as an everting cathetersystem 106) that can be used to traverse a vessel, such as the cervicalcanal is disclosed. The everting balloon system 8 can be used to accessthe uterine cavity via the cervix. The cervical canal is a single lumenvessel that can stretch or dilate. The everting balloon system 8 canhave a control system that can be operated with one hand. Thepressurization states or configurations of the everting catheter system106 can be changed and controlled with one hand of the user.

FIGS. 1A through 1E illustrate that an everting catheter system 106 canhave a radially outer catheter 2, a balloon membrane 6, and a radiallyinner catheter 10. The inner catheter 10 can have an inner catheterlumen 12 (e.g., a through-lumen). The distal end of the inner catheterlumen 12 can be open or closed. The inner catheter 10 can have the innercatheter lumen 12, or be a solid rod or flexible mandrel, or containmultiple lumens for the delivery of other agents, tools, catheters,instruments, endoscopes, and other media. The inner catheter 10 can bemade from multiple polymeric materials and have a more flexible distalend and more rigid proximal end. Distal end flexibility can be enhancedwith the incorporation of a distal end coil or spring 150 to providedistal end flexibility and support from kinking the lumen of the innercatheter 10. The internal lumen of the inner catheter 10 can be madefrom a lubricious material such as Teflon or coated with a lubriciouscoating to facilitate the passage of instruments, tools, or othercatheters through the internal lumen.

The everting balloon system 8 can have a media volume 4. The mediavolume 4 can be the contiguous open volume between the inner catheter 10and outer catheter 2 that is proximal to the balloon membrane 6. Aradially outer terminal perimeter of the balloon membrane 6 can beattached to the distal terminal end of the outer catheter 2. A radiallyinner terminal perimeter of the balloon membrane 6 can be attached tothe distal terminal end of the inner catheter 10.

FIG. 1A illustrates that the everting catheter system 106 can be in anunpressurized configuration. The media volume 4 can be uninflated andunpressurized. The balloon membrane 6 can be slack.

FIG. 1B illustrates that everting catheter system 106 can be in apressurized and uneverted configuration. A pressurization device, suchas a pump, for example at the proximal end of the everting cathetersystem 106 can be in fluid communication with the media volume 4. Thepressurization device can deliver a fluid media, such as a pneumatic gasor hydraulic liquid media (e.g., saline, water, culture media, air,carbon dioxide, air-infused fluids, carbonated fluids, or combinationsthereof), at a media pressure 14 to the media volume 4. The mediapressure 14 in the everting balloon 22 can be from about 2 to about 5atmospheres of pressure when in the everted configuration and highermedia pressures 14 from about 5 atmospheres to 10 atmospheres arepossible, for example, to provide greater everting capability for moredifficult or stenotic passageways in the body.

The balloon membrane 6 can inflate and be in tension. The balloonmembrane 6 can block the distal port of the inner catheter lumen 12.

The everting catheter system 106 can have an everting catheter systemdistal end 210 and an everting catheter system proximal end 214.

FIG. 1C illustrates that the everting catheter system 106 can be in aninflated and partially everted configuration. The inner catheter 10 canbe translated distally, as shown by arrow 16, with respect to the outercatheter 2, and out of the outer catheter 2. The distal terminal end ofthe inner catheter 10 can be proximal of the distal terminal end of theballoon membrane 6. The distal terminal end of the inner catheter 10 canbe proximal or terminal of the distal terminal end of the outer catheter2. The balloon membrane 6 can block the distal port of the innercatheter lumen 12 or can be open allowing fluid communication betweenthe inner catheter lumen 12 and the target site.

FIG. 1D illustrates that the everting catheter system 106 can be in aninflated, fully everted, and fully distally extended configuration. Theinner catheter 10 can be translated distally, as shown by arrow 16, withrespect to the outer catheter 2 until the distal terminal end of theinner catheter 10 is longitudinally beyond or co-terminal with thedistal terminal end of the balloon membrane 6. The distal port of theinner catheter lumen 12 can be unobstructedly accessible and in fluidcommunication with the target site.

In the fully inflated configuration, the balloon membrane 6 can form aninflated everting balloon 22. The everting balloon 22 can have a balloonouter diameter 20 and balloon length 18 in the inflated and fullyeverted configuration.

The balloon outer diameter 20 can be from about 2 mm to about 20 mm,more narrowly from about 2 mm to about 7 mm, for example about 3.0 mm.The outer diameter can be constant or vary along the length of theeverting balloon 22. For example, for use in the cervical canal, themost proximal portion of the everting balloon outer diameter 22 could beconfigured with a smaller outer diameter than the remainder of theeverting balloon membrane 6. As an example, the first proximal portionof the everting balloon 22 can have a smaller balloon outer diameter 20such as from about 2 mm to 4 mm for a length of from about 5 mm to about10 mm from the distal terminal end of the outer catheter 2, and theremainder of the length (e.g., from about 4 cm to about 7 cm along theeverting balloon 22) of the everting balloon 22 can have a balloon outerdiameter 20 from about 4 mm to about 7 mm.

The interior surface and lumen of the balloon can be coated with alubricious material to facilitate rolling and unrolling of the interiorsurfaces of the everting balloon membrane 6.

The exterior surface of the balloon membrane 6 can be configured withridges, projections, bumps, grooves, and additional surface ormechanical features, or combinations thereof, for example for increasedfriction or holding power within the vessel.

The everting balloon 22 length 18 can be from about 2 cm to about 10 cm,more narrowly from about 3.5 cm to about 8.5 cm (e.g., for use in alonger uterine cavity lengths), yet more narrowly from about 5 cm toabout 7.5 cm.

FIG. 1E illustrates that the everting catheter system 106 can be in aninflated and partially or fully everted configuration. A tool, liquid,gas, or combinations thereof can be translated, as shown by the arrow,through the inner catheter lumen 12, out of the distal port of the innercatheter lumen 12 and into the target site. The tool 24 can be a biopsytool, a scope, a sonogram probe, a plug, a cauterization tool, orcombinations thereof. Suction can be applied from the proximal end ofthe inner catheter lumen 12, and to the target site, for exampleremoving debris from the target site through the inner catheter lumen12. For use in IVF procedures, an embryo transfer catheter 28 istranslated through the inner catheter lumen 12 for deposition ofembryo(s) or other reproductive material such as gametes or sperm.

To retract and reposition or remove the balloon membrane 6, the innercatheter 10 can be pulled proximally to pull the balloon membrane 6 backwithin the outer catheter 2. The balloon membrane 6 can be deflated orhave media pressure 14 reduced and the entire system can be withdrawnfrom the target site.

FIG. 2A illustrates an everting balloon system 8 that can have adelivery catheter 32, embryo transfer catheter 28, and a pressurizationsyringe 30. The embryo transfer catheter 28 can be translatably slidinto and/or partially through the delivery catheter 32 (e.g., with thedistal end of the embryo transfer catheter 28 extending out of thedistal terminal end of the delivery catheter 32). The pressurizationsyringe 30 can be detachably connected or attached to the proximalterminal end (e.g., at a luer lock) of the delivery catheter 32 and/orthe embryo transfer catheter 28, and/or the

FIG. 2B illustrates that the delivery catheter 32 distal end can have aneverting balloon 22 that can be in a fully everted configuration. Theeverting balloon system 8 can be equipped with a distal end opening or apre-determined valve.

FIG. 2C illustrates the embryo transfer catheter distal end 36 canextend beyond the distal end of the fully everted everting balloonmembrane 6. The everting catheter system 106 can access a bodily cavity(e.g., the uterine cavity or fallopian tubes) to deliver or introducetools (e.g., instruments), reproductive media or material (e.g.,embryos, in vitro fertilization (IVF) or insemination products, such ashormones), contrast media, dye, therapeutic agents, sclerosing agents totreat the endometrium, insufflation media, or combinations thereof tothe cavity. For example, reproductive media can be delivered with atransfer catheter inserted through the inner catheter lumen 12 to theuterine cavity.

FIG. 2B illustrates that a transfer catheter or insemination cathetercan have a transfer connector 34, such as a female luer connector, astrain relief length, and a transfer tube. The transfer tube can holdthe reproductive media. A delivery force, for example a positive fluidpressure, can be delivered through the transfer connector 34 and strainrelief length to push the contents of the transfer tube into the targetsite.

The transfer catheter can attach to or inserted through the inlet port.The transfer tube can hold an embryo, for example for in vitrofertilization or IVF. The embryo transfer catheter 28 can deliverembryos through the system and to the uterine cavity and other agentsthat help facilitate embryo implantation such as materials that promoteadherence of the embryo to the uterine endometrium. The embryo transfercatheter 28 can have a distal end configuration that can promoteimplantation of the embryo(s) within the endometrial wall or within thesub-endometrial surface.

The embryo transfer catheter 28 can hold spermatozoa and deliver thespermatozoa through the system and to the uterine cavity forintrauterine insemination procedures. The transfer catheter can hold anddeliver or deposit materials, such as drugs, therapeutic agents,instruments, endoscopes, cytology brushes, other catheters, orcombinations thereof through the system and into the uterine cavity. Thetransfer catheter can be connected to a vacuum source for the aspirationof materials from the uterine cavity or other bodily cavities andlumens.

The transfer catheter and/or materials can be loaded in the innercatheter lumen 12 prior to everting the everting balloon 22 within thevessel or bodily cavity. For example in the case of delivery ofreproductive material in the uterine cavity, the transfer catheter canbe loaded with washed and prepared semen in the transfer tube and thetransfer catheter can be placed in the inner catheter lumen 12.

The inner catheter 10 can be extended and the everting balloon 22 canevert and unroll through the cervix and into the uterine cavity.Concurrently or subsequently, the transfer catheter can be advancedthrough the inner catheter lumen 12 into the uterine cavity. Once fullyeverted or when the transfer catheter becomes extended or exposed fromthe inner catheter 10 and beyond the everting balloon membrane 6, thereproductive material in the transfer catheter can be deposited by asyringe 66, squeeze bulb, piston, or other pressure system. A seconddelivery catheter 32, such as a second insemination, IVF, or drugdelivery catheter 32 can be concurrently inserted into the inlet port ora second inlet port. The second delivery catheter 32 can be deployed tothe target site concurrent with or subsequent to the transfer catheter.The embryo transfer catheter 28 can advance distally within the evertingballoon 22 and the inner catheter lumen 12. The transfer catheter candeposit the reproductive material (e.g., sperm) within the uterinecavity.

FIG. 3A illustrates a cross-sectional view of a flexible tip guidancewire 44 extending beyond the distal terminal end of the everting balloonmembrane 6 during the eversion process directing the everting balloonsystem 8 beyond an endocervical canal cul-de-sac 40. The distal end ofthe delivery catheter 112, for example the delivery catheter acorn tip48, can be seated against or near the cervical entrance 38. The flexibletip guidance wire 44 can be advanced beyond the opening of thecul-de-sac 40 and can be positioned within the cervical entrance 38 oropening towards or within the uterine cavity entrance 42. The deliverycatheter 32 system can be equipped with a flexible tip guidance wire 44that allows the physician to steer or direct the leading edge of theeverting balloon 22 to the correct path within the uterus, for example,to facilitate access within the uterine cavity entrance 42 and throughthe cervical canal.

The delivery catheter 32 system can be used, for example, when a defect,such as a C-section defect or scar, cul-de-sac 40, or crypt is presentwithin the endocervix. Such defects can be visualized before, during orafter delivery of the flexible tip guidance wire 44, via transabdominalor transvaginal ultrasound. The echogencitiy of the delivery catheter 32is enhanced by pressurization fluid, or air, or a combination of boththat creates echogenic density differences that are visualized byultrasound. The flexible tip guidance wire 44 can be introduced beyondthe cul-de-sac 40 opening and towards the uterine cavity or target site,for example, to avoid the defect or cul-de-sac 40. The internal balloonpressure can be reduced or eliminated, for example, to advance theflexible tip guidance wire 44 beyond the everting balloon distal end 46.With everting balloon pressure low or at zero, the flexible tip guidancewire 44 can be threaded through the deflated balloon membrane 6 andadvanced beyond the cul-de-sac 40 opening. Once the flexible tipguidance wire 44 is advanced beyond the opening and towards the targetsite, the everting balloon membrane 6 pressure can be re-established andthe advancement of the inner catheter 10 can continue until the evertingballoon distal end or leading end moves past or distal to the cul-de-sac40 opening.

FIG. 3B illustrates a cross-sectional view of a flexible tip guidancewire 44 beyond the distal end of the everting balloon membrane 6 at thecompletion of the eversion process beyond a cul-de-sac 40 in theendocervical canal. In this view, the everting balloon system 8 has beenadvanced towards and within the uterine cavity without entering thecul-de-sac 40. Once past the opening and towards the uterine cavity ortarget location, the flexible tip guidance wire 44 can be removed oncefull eversion is complete, or prior to that by reflating the evertingballoon 22 pressure to allow removal of the flexible tip guidance wire44.

FIG. 4 illustrates a variation of the everting balloon system 8 in afully everted configuration and with a stopcock 52, for example, formaintaining pressurization. The stopcock 52 can be attached to or placedon the Y-fitting 50 connector which can be used by the physician to holdthe everting balloon system 8 during the procedure. The location of thestopcock 52 lateral to the body of the catheter can allow finger-tipcontrol of the pressurization state of the everting balloon system 8 bymanipulating the stopcock 52 orientation with the physician's fingers.At the completion of the eversion for the inner catheter 10, thepressurization state of the everting balloon membrane 6 can be quicklyremoved. The removal of the pressurization state can occur prior to,during, or after the insertion of the embryo transfer catheter 28.Alternatively, the removal of the pressurization state can occur priorto, during, or after the deposition of the embryo(s) from the embryotransfer catheter 28. Yet further, the removal of the pressurizationstate can occur prior to, during, or after the removal of the embryotransfer catheter 28. Once the pressurization state is removed from theeverting balloon system 8 and after the embryo(s) have been depositedwithin the uterine cavity, the entire everting balloon system 8 can bewithdrawn from the uterine cavity.

FIG. 5A illustrates a variation of the everting balloon system 8 with aninternal alignment mechanism 56 that can prevent or minimize rotationand spinning of the balloon membrane 6. The twisting of the balloonsystem can be restricted or eliminated. Multiple twists within theballoon system can, for example, hinder the advancement of the embryotransfer catheter 28 or other instruments and tools through the evertingballoon system 8. An internal alignment mechanism 56 of alignment piececan be located within the outer tubing 54 distal to the Y-fitting 50 andstasis valve that can maintain pressurization within the evertingballoon system 8 while the inner catheter 10 within the deliverycatheter 32 is being advanced or retracted during the eversion process.

FIG. 5B illustrates a cross-sectional axial view of the internalalignment mechanism 56 and mating geometry of the delivery catheter 32tubing. The inner surface of the outer tubing 54 of the deliverycatheter 32 can have a D-shaped configuration. The alignment piece onthe inner catheter 10 can be keyed within the D-shape of the outertubing 54, for example, to restrict or eliminate the rotation of theinner catheter 10 in relation to the outer tubing 54. The alignmentpiece can be made from a material with a lubricous coating, Teflon, orother material that reduces the friction of the alignment piece whenbeing moved in the outer tubing 54.

The D-shape can alternatively be an oval or elliptical shape, with amating oval or elliptical shape on the alignment piece that restricts oreliminates the rotation of the inner catheter 10 in relation to theouter tubing 54.

Alternatively, the alignment piece shape can be configured as theexternal surface throughout the entire inner catheter 10 tubing body.The shape of the external surface would in this configuration mate withthe internal geometry of the outer tubing 54. The surfaces can “key”into each or interference fit against each other, for example, torestrict or eliminate the rotation of the inner catheter 10 to the outertubing 54 and the stasis valve would need to conform or fit to theexternal surface of the inner catheter 10 to maintain pressurizationduring the eversion process. As an example, the inner catheter 10 tubingcan be configured with a rail surface or protrusion that mates or “keys”with receptacle within the outer tubing 54 internal geometry.

FIG. 5C illustrates that the alignment piece can have splines 58extending radially outward from the inner catheter 10. The splines 58can abut or mate within the internal geometry of the outer tubing 54.The spline outer surfaces can engage the internal geometry of the outertubing 54, for example, to restrict or eliminate the rotation of theinner catheter 10 in relation to the outer tubing 54. The splinesurfaces can have minimal edges or corners that can have a reducedsurface area contacting the internal walls of the outer tubing 54. Thereduction of surface area can reduce the friction of the alignment piecewhen moved within the outer tubing 54.

FIG. 6 illustrates that the everting balloon system 8 can have aninternal mechanism stopper 64. The outer tubing 54 of the deliverycatheter 32 can have a crimp 62. The internal mechanism stopper 64 canprevent or minimize over-elongation of the inner catheter 10 duringballoon inversion by abutting or interference fitting against the crimp62. In use during the eversion and inversion procedure, or during thepreparation of the everting balloon system 8, the end user or physiciancan inadvertently retract the everting balloon system 8 and over-extendthe balloon membrane 6. The over-extension can stretch, weaken, ordamage the balloon membrane 6. Visual indicators or markings are usefulbut may not prevent over-extension if the end user is not diligent or iswithin a setting in which the indicia is readily visual. The stopper 64is located on the inner catheter 10 tubing body and is positioned atpoint where full inversion has occurred. At full inversion, the stopper64 contacts a mechanical detent, crimp 62, stop, or the distal end ofthe Y-fitting 50 connection, and prevents further retraction of theinner catheter 10 thereby eliminating the over-extension of the balloonmembrane 6 beyond the full inversion state. The stopper 64 couldmechanically contact other mechanical structures built into the outertubing 54 such as a crimp 62 as shown in FIG. 6, or a reduction ininternal diameter of the outer tubing 54, in which the stopper 64 wouldengage the crimp 62 or reduction in internal diameter of the outertubing 54 to physically prevent further retraction of the inner catheter10 beyond the full inversion state.

FIGS. 7A, 7B and 7C illustrate that the everting balloon systems 8 canhave a compliant pressurization apparatus or element that can provide apre-determined pressure within the catheter system with an indicator tothe user that the system is at the appropriate operating pressure.

FIG. 7A illustrates that a compliant member 68 can be in the evertingballoon system 8. The compliant member 68 can be configured as aseparate component or accessory to assist the end user in preparing theeverting balloon system 8. As the pressurization of the everting balloonsystem 8 occurs, for example as fluid 70 is pressed from the syringe 66into the everting balloon system 8, the compliant member 68 can inflate.The inflation of the compliant member 68 can be a visual indicator thatthe system contains pressure. The compliant member 68 can be made fromsilicone tubing or balloon, other elastomeric materials such aspolyurethane, rubber, latex, or combinations thereof. The compliantmember 68 can be configured as one or more tubing or balloons.

FIG. 7B illustrates that the compliant member 68 can expand radially andlengthwise upon the influence of instilled fluid media from the syringe66. The expansion of the tubing walls of the compliant member 68 can actto dampen the fluid pressure within the everting balloon system 8. Thiscan allow for variance in the amount of fluid 70 instilled by the enduser that could impact the pressure rise in the everting balloon system8. The amount of air in the everting balloon 22 also provides somecompliance to the everting balloon system 8 and hence the complaintmember can provide a range of fluid volumes without exceeding therecommended working pressure of the everting catheter system 106.

As a representative example, one embodiment of the everting cathetersystem 106 can operate in a pressure range from about 2 to about 4atmospheres of pressure with a nominal pressure of about 3 atmospheres.For advancement within the cervical canal and into the uterine cavity,any residual air within the everting balloon system 8 can be removedbefore, during and/or after the eversion process. This can beparticularly advantageous in situations with tight or stenotic cervices.One method to achieve a working pressure of 3 atmospheres is to connecta pressure gauge to the everting balloon system 8. In practice pressuregauges and inflation devices are expensive to the overall cost of thesystem. Another method to achieve a working pressure of 3 atmospheres isto prescribe an exact fluid volume amount to the everting balloon system8 that must be instilled by the end user prior to use. In practice thiscan accomplish a working pressure of 3 atmospheres but requiresdiligence by the end user to both fluid volumes and the amount of air inthe everting balloon system 8. The attachment of the compliant member 68to the everting balloon system 8 can accomplish consistent fluidpressures within a wider range of fluid volumes that provides a largertolerance to end user diligence during the catheter preparation process.This is demonstrated with a compliant member 68 attached to an evertingballoon system 8 with a recommended fill volume of 3 cc of fluid 70. Fortest purposes while measuring preparing the everting catheter system 106with varying amounts of fluid volume, the internal pressure of thesystem does not alter (much) beyond the nominal pressure of 3atmospheres and in all fluid volumes, even when the fluid volume isintentionally doubled beyond the instructed amount, the internalpressure of the everting balloon system 8 can remain within theoperating working range of the system. For this test, the complaintmember is constructed with 50 durometer silicone tubing with a 0.250″ IDand a 0.500″ OD and a 1.5 cm length of silicone tubing. At the ends ofthe compliant member 68 (e.g., silicone tubing) can be male and femaleluer connectors with attachment rings to mechanically adhere thesilicone tubing to the luer connectors. As the silicone tubing is filledwith fluid 70, the radial walls can expand and the overall length of thesilicone tubing can increase in response to the increasing volume offluid 70. The internal fluid pressure of the everting balloon member canplateau at or near the desired nominal pressure amount, for examplesince the additional fluid volume is accommodated by the compliantmember.

Fluid Volume Within Resultant Internal Everting Balloon System PressureWithin the and Complaint Member Everting Balloon System 3 cc of saline3.0 atmospheres 4 cc of saline 3.0 atmospheres 5 cc of saline 3.2atmospheres 6 cc of saline 3.3 atmospheres

As seen in the above exemplary data table, the resultant internalpressure can remain within the specification range from about 2 to about4 atmospheres and at or near the nominal pressure of 3 atmospheres. Inthis set of experiments and with this configuration of the complaintmember, a fluid volume of about 2× the amount yielded a 10% increase ininternal pressure. By altering the durometer, elastormeric properties,length and wall thickness of the compliant, other nominal pressureamounts can be obtained. One of the additional benefits of the compliantmember 68 is that it provides a safety margin againstover-pressurization that can either damage the balloon system, orprovide an everting balloon system 8 that operates outside of itsoperational working parameters. The complaint member can be used incombination with a pressure relief valve in everting balloon systems 8that have more critical or tight pressure tolerances, or where internalpressure changes due to operator or anatomical factors can createinternal pressures that go beyond the normally-expected performancespecification.

FIG. 7C illustrates that the compliant member 68 can be located on theouter tubing 54 of the everting balloon system 8. The location of thecompliant member 68 can be a visual indicator to the physician on thepressurization state of the everting balloon system 8 and can impact theinternal pressure of the everting balloon system 8 due to its complianceproperties. The complaint member can be made from elastomeric materialssuch as silicone, polyurethane, PVC, rubber, latex, or combinationsthereof. The compliant member 68 can be shaped as a tube or a preformedballoon.

The entire compliant member 68 can be held by the physician during use.The entire complaint member can be grasped and squeezed whilemaintaining positional control of the everting balloon system 8.

Squeezing (i.e., applying external mechanical pressure) the complaintmember circumferentially can create small rises in the internal pressureof the everting balloon system 8 that can advance the everting balloon22 through tight or narrow anatomical passages. Relaxing the grasp(i.e., external mechanical pressure) on the complaint member wouldinstantly return the complaint member and the everting balloon system 8to the pervious operating pressure range. The complaint member can bepulsed or vibrated (e.g., with external mechanical pressure), forexample, providing pulsatile fluid pressure spikes within the evertingballoon system 8, for example for advancement through tight or narrowpassageways and/or advancement of the everting balloon 22 in small anddiscrete steps, and/or with minor increases in internal pressure.

FIG. 8 illustrates that the everting balloon system 8 can have amechanism that automatically pressurizes the everting balloon system 8to a predetermined amount. In a side view, a rigid compliance canister72 that has a syringe plunger 74 and spring assembly 76 can be attachedto or configured onto the everting balloon system 8. The chamber canhave a fluid reservoir 82 filled with a fluid 70 in communication withthe internal volume of the everting balloon system 8 and in contact withthe syringe plunger 74. The fluid 70 can supply internal pressure to theeverting balloon 22. The syringe plunger 74 and spring assembly 76 canhave a spring 150 that can drive the plunger into the chamber with aknown spring 150 constant or K factor. The spring 150 can deliver apredetermined internal pressure to the everting balloon system 8. Thespring 150 can provide fluid 70 or pressure compliance to the evertingballoon system 8 to maintain the internal pressure within the operatingrange and the spring 150, like the complaint member, can be responsiveto changes in fluid volume, the everting balloon system 8 itself as iteverts and inverts, and any anatomical forces acting on the evertingballoon system 8.

The everting balloon system 8 can have a syringe plunger 74 and airpressure canister 72 (e.g., in combination with or in place or thesyringe plunger 74 and spring assembly 76 shown in FIG. 8) in which theair canister 72 has a predetermined internal gas pressure (e.g.,providing fluid compliance like the spring assembly 76). Pressure fromthe air canister 72 acting on the plunger can drive the fluid volumewithin the everting balloon system 8 to a predetermined internalpressure range. The air pressure canister 72 can be prefilled with CO2gas, air, or other gas.

FIG. 9A illustrates that the everting balloon system 8 can have anintegral pressurization system 88 that can provide an indicator and theability to quickly shift the pressurization state of the balloon systemfrom pressurized to non-pressurized at the fully everted state of theeverting balloon system 8 via actuating slide or trumpet valves forfluid 70 from a constant pressure source 84 to a separate fluidreservoir 82. Actuation of trumpet valves directs fluid 70 back into theconstant pressure source 84 through one-way valves 86. The one-wayvalves 86 can be part of the trumpet valves. A stopcock 52 is used toprepare and fill the everting balloon system 8 with fluid 70. Forexample, a first trumpet valve 78 an release fluid 70 into the fluidreservoir 82, and a second trumpet valve 80 can return to the constantpressure source 84.

FIG. 9B illustrates an everting balloon system 8 with an integralpressurization system that provides an indicator and the ability toquickly shift the pressurization state of the balloon system from highpressurization to low pressurization, and back to high pressurization,or multiple intermediate states of pressurization, during the eversionprocess. A switch valve diverter and diaphragm 90 on the fluid reservoir82 can open and close the fluid pathway into the everting balloon system8 from the constant pressure source 84 and fluid reservoir 82.Depressing the plunger or diaphragm 90 of the fluid reservoir 82 returnsthe fluid volume back into the everting balloon system 8 and incommunication with the constant pressure source 84. While fluid 70 isdiverted into the fluid reservoir 82, the internal pressure within theeverting balloon system 8 drops to, or at, nears zero atmospheres.Depressing diaphragm 90 plunger of the fluid reservoir 82 pushes fluid70 through one-way valve 86 into the constant pressure source 84chamber. Manual depression forces on the diaphragm 90 are facilitated bythe flexure of the diaphragm 90 surface from a convex profile to aconcave profile as the fluid is pushed through the one-way valve 86 andinto the constant pressure force chamber. Fluid 70 going into theconstant pressure force chamber flows through a one-way valve 86 toenter the chamber. Once the diverter is flipped back to the evertingballoon system 8, the constant pressure source 84 will instill the fluid70 back into the everting balloon 22. Other combinations of one-wayvalves 86, check valves, or turn valves are possible to allow fluidpressure in the everting balloon systems 8 to change from an operatingpressure state or a zero pressure state quickly without having toreconnect to the everting catheter 218 to a separately supplied fluidsource, or without moving the position of the everting catheter 218within the bodily cavity.

As another embodiment, the constant pressure source 84 could beconfigured to supply varying amounts of force for providing the internalpressure of the everting catheter system 106. The constant pressuresource 84 can be supplied with a constant pressure regulator 92 that canmodulate the amount of internal pressure being supplied to the evertingballoon system 8. Pressure modulation can provide change from 3atmospheres of pressure to 2, 1, or 0.5 atmospheres of pressure whichcan still provide the everting balloon 22 with structural shape butreduces the amount of eversion force, or the overall diameter of theeverting balloon 22. In practice, as an example, the everting balloon 22may have its internal pressure modulated from 3 atmospheres of pressureat a point of nearly complete eversion but would then have the internalpressure modulated to 0.5 or 1 atmospheres of pressure as the embryotransfer catheter 28 is being loaded by the embryologist, or when theembryo transfer catheter 28 is being traversed through the innercatheter 10, or at as the entire everting catheter 218 is inverted orremoved from the uterine cavity without inverting the balloon back intothe delivery catheter 32. Other degrees of pressure are possible withfingertip control of the physician without having to use an inflationdevice hooked up to the everting catheter system 106.

The everting balloon system 8 can have a fill port 94, for example tofill and/or empty the everting balloon system 8 (e.g., the evertingballoon 22, constant pressure source 84, fluid reservoir 82, catheterinner volumes, connector inner volumes, or combinations thereof) withfluid 70.

FIG. 10 illustrates an everting balloon system 8 with a mechanism thatstabilizes the inner catheter 10 at the full eversion stage and providesan indicator to the user that catheter system is at the appropriate stepin the process for embryo transfer. For this embodiment, the innercatheter 10 and the everting balloon 22 reach full eversion when theinner catheter proximal hub 98 contacts the Y-fitting cap 100 of thedelivery catheter 32. Receptacle on Y-fitting cap 100 is configured toaccept and mate with the distal surface of the proximal hub. Contact ofthe inner catheter proximal hub 98 to the cap of the Y-fitting 50 canelevate a pop-up locking tab as a visual indicator of the engagedposition. Mating action can be an audible or palpable, or both, as thetwo surfaces engage and lock. For the embryo transfer procedure, whenthe two surfaces engage and lock, the embryologist can provide theembryo transfer catheter 28 for traversing through the inner catheter10. Depression of the pop up locking tab 96 to unlock can free the innercatheter proximal hub 98 from the mating surface. The two surfaces canengage without locking, or engage with a mechanical or friction fit thatcan be overcome by slight retraction by the physician. The mating actionof the two surfaces can mechanically open turn valve on the Y-fitting 50to remove internal pressure within the everting balloon system 8 toreduce profile of the everting balloon 22, for example, once the fulleversion process is completed.

FIG. 11 illustrates in a side cross-sectional view an everting balloonsystem 8 with a proximal hub connector that can have a funnel, forexample, for aiding the physician and embryologist in delivering theembryo transfer catheter 28 to the inner catheter lumen 12 of thedelivery catheter 32. The inner catheter proximal hub 98 can have alarge funnel opening 102, for example, to provide a target for theembryologist or the physician to place the distal end of the embryotransfer catheter 28 into the everting catheter system 106. The funnelof the proximal hub can also have a funnel posterior extension 104 thatprovides a platform for resting the proximal end of the embryo transfercatheter 28 during the final steps of embryo transfer catheter 28insertion. This may be particularly beneficial with embryology syringes66 that are heavy in weight, such as glass syringes 66, that couldcreate extra downward forces on the embryo transfer catheter 28.

FIGS. 12A and 12A′ illustrate a side view and a perspective view whilein the grasp of a hand, respectively, of an everting balloon system 8shaped with distal end features that facilitate uterine access withoutthe need for a speculum. During embryo transfer procedures, minimizingthe manipulations to the patient's uterus, cervix, and vagina is bothmore comfortable to the patient but can also have a significant role inreducing the amount of uterine contractions that could spontaneouslyarise during a procedure as a result or response to the manipulations.Uterine contractions can have a deleterious effect to the implantationof embryos during a procedure. The insertion of a speculum itself hasbeen demonstrated to elicit uterine contractions and is uncomfortable tothe patient. The embodiment of the everting catheter system 106 in FIGS.12A and 12B also facilitates the use of a transvaginal ultrasound probe198 during the embryo transfer procedure. Transvaginal ultrasoundprovides greater vision quality than an abdominal ultrasound in whichthe abdominal ultrasound probe needs to provide sound waves through thepelvic region of the patient which may have varying degrees of abdominalfat. Also abdominal ultrasound is enhanced by the patient having a fullbladder which can also add to the discomfort to the procedure. The useof a transvaginal ultrasound probe 198 during an embryo transferprocedure is difficult since existing embryo transfer catheter 28systems require a speculum for insertion of the device into the cervix.The embodiment illustrated in FIGS. 12A and 12B is designed to providerigidity to enter into the vagina and press off the posterior surface ofthe vagina. Distal end angulation or curvature is designed to direct thedistal tip of everting catheter 218 towards to cervical os.

FIG. 12B illustrates that the acorn tip 110 can be shaped for placementalongside the transvaginal ultrasound probe 198 by having flat surfaces116 on either side of the acorn tip 110. The acorn tip 110 can have adistal end hole 114 or port. The physician can place the transvaginalprobe into the vagina and alongside the cervix. The everting cathetersystem 106 can be introduced alongside the transvaginal probe until theacorn tip 110 is at the exocervix. The presence of the transvaginalultrasound probe 198 would create access, and in most cases, room in thevagina for visual confirmation of placement at the exocervix without theneed for a speculum. The everting balloon 22 would be then placed intothe endocervical canal. For an everting catheter system 106, the portionof the everting catheter 218 that contacts the endocervix and uterinecavity is all contained within the delivery catheter 32 and does notcontact the surfaces or fluids in the vagina, thus further obviating theneed for a speculum during the procedure. As shown in FIG. 12A, theposterior side of delivery catheter 32 has a curved flexure support 108.Flexure support 108 is designed to maintain distal end curvature forentry into the vagina and placement of the distal acorn tip 110 at theexocervix. Flexure support 108 has rigidity to push slightly downward inthe vagina to retract vaginal tissues away from the cervix 202. FIG.12A′ shows the curvature of the delivery catheter 32.

FIG. 12B illustrates that the distal end with flat surfaces 116 on bothsides of the acorn tip 110 can facilitate placement along either side ofthe transvaginal ultrasound probe 198 regardless of the physician beingright or left handed.

FIG. 13 illustrates in a side view of an everting balloon system 8 witha handle 120 and controller 118 that can control the translation 26(e.g., advancing and retracting of) of the inner catheter 10. Handle 120is designed to minimize the amount of overall working length of theeverting catheter system 106 without adding length to the evertingcatheter system 106.

As an example, working space needed to place a handle 120 within aneverting catheter system 106 can increase the overall length to thedelivery catheter 32, inner catheter 10, and the embryo transfercatheter 28 that needs to be placed within the system. Adding length tothese systems can create handling issues within the embryologylaboratory, especially in labs in which the loading of embryos withinthe embryo transfer catheter 28 is performed within a small incubatorwith side walls that will encroach on the handling of the embryologysyringe 66 and placement of the distal end of the embryo transfercatheter 28 within the embryo dish within the incubator. The addedlength in these situations would create handling and manipulationchallenges for the embryologist. The handle 120 can reduce the amount ofworking length occupied by the handle 120 and controller 118 mechanismwhile still providing a one-handed operation to the advancement of theinner catheter 10 during use. The handle 120 contains gear wheelcontroller 118 mechanism for engaging and translating the inner catheter10 during use. The handle 120 can have a posterior section that can becurved to fit the palm and fingers of the physician without requiringthe inner catheter 10 to be placed through the handle 120 portion forengagement with the controller 118 mechanism. The handle 120 can have apistol grip with gear wheels actuated by the thumb. The handle 120 canbe incorporated into an everting catheter system 106 for use withtransvaginal ultrasound.

FIGS. 14A and 14A′ illustrate that the everting balloon system 8 canhave a translatable and adjustable distal end tip 122 that can alter theworking length of the everting balloon 122. The translatable andadjustable distal end tip 122 can have a connector 124 on its proximalend and an acorn tip 110 on its distal end that can be advanced orretracted on the distal end of the delivery catheter 112. Advancement ofthe translatable and adjustable distal end tip 126 can reduce theoverall length of the everting balloon 122 within the bodily cavitywithout impacting the markings on the proximal end of the embryotransfer catheter 28.

FIGS. 14B and 14B′ illustrate that the translatable and adjustabledistal end tip can be at an extended position with the resultant workinglength of the everting balloon 122. As an example, the everting balloonsystem 8 can have a 5 cm long everting balloon 22 has the translatableand adjustable distal end tip advanced 3 cm on the delivery catheter 32.The resultant new working length of the everting balloon 22 in the bodycavity can be 2 cm. The connector 124 on the proximal end of thetranslatable and adjustable distal end tip can be rotated to engageedges of D-shape outer tubing 54 of the delivery catheter 32. Oncerotated in the locked position, the translatable and adjustable distalend tip can no longer move or slide on the delivery catheter 32.Unlocking the connector 124 by rotation will return translationalmovement to the translatable and adjustable distal end tip. Other typesof connectors 124 are possible including twist valve that resistmovement by friction on the outer tube of the delivery catheter 32 andcan be untwisted to allow movement. Another example of a connector 124is a clip that has an engaged and disengaged position which is actuatedby the user.

FIGS. 15A and 15A′ illustrate a protective tube system 128 for theembryo transfer catheter 28 that facilitates handling and transport ofthe catheter. The protective tube can be shipped assembled with two tubecomponents with male and female connections 130 attached to each otherwith the embryo transfer catheter 28 within the lumen of the protectivetube.

FIGS. 15B, 15B′, and 15B″ illustrate a protective tube system 128 forthe embryo transfer catheter 28 in the detached configuration for theloading of embryos. The female connection can be at the protective tubefemale end 132. The female connection of the tube component can beseparated from the male connection 134 at a point near the distal end ofthe embryo transfer catheter 28, leaving a distal portion of the embryotransfer catheter 28 exposed for working under microscopic vision andthe loading of embryo(s) and/or reproductive materials. FIG. 15B″ showsthe handling of the embryo transfer catheter 28 and the exposure of theembryo transfer catheter distal end 36 when loading embryos with anembryology syringe 66.

FIG. 15C illustrates a protective tube system 128 for the embryotransfer catheter 28 in the re-attached configuration to cover theembryo transfer catheter distal end 36 with the protective tube, forexample, for the transport of the embryo transfer catheter 28. Onceloaded with embryo(s) and reproductive materials, the female connectioncan be reattached to the male connection for transport to the patientand the delivery catheter 32 system. The connection point 136 (betweenthe male and female connections 130) in the protective tube can beopened to gain access to the distal end of the embryo transfer catheter28 for manipulation under a microscope or within an embryologyincubator. The connection point 136 can be re-attached for eventualtransport to the patient and the completion of the embryo transferprocedure.

FIG. 16 illustrates an everting catheter system 106 that has a couplingelement to attach to the TUS probe. The coupling element is attached tothe delivery catheter 32 portion of the everting catheter system 106.The coupling element can have a probe attachment clip 140 that canattachably engage or fit onto the shaft of a transvaginal ultrasound(TUS) probe. The clip can have an arm that can encircle and attach tothe TUS probe and the arm is rotated about a pin 138 to clamp onto theTUS probe. The pin 138 can be attached to a rotating clip on the TUSprobe. The attachment of the everting catheter system 106 to the TUSprobe can allow the physician to hold onto the TUS probe whilemaintaining the position of the everting catheter system 106 in situ,thereby leaving a hand free to pass a transfer catheter, or actuatecontrols on the ultrasound console, or steady the patient. Importantly,the coupling element while attached to the TUS probe allows thephysician to control the visualization of the ultrasound imaging whileactuating the everting catheter 218, passing a transfer catheter, makingthe deposition of reproductive matter into the uterine cavity, andremoving the entire system from the patient's uterine cavity; all whileunder direct ultrasound visualization control of the physician.

FIG. 17A illustrates an everting catheter system 106 with a spring 150loaded inner catheter 10 for automatically translating the innercatheter 10. Fluid 70 can be delivered through the fill port 94 and/orinflation lumen 160, for example, to pressurize the balloon membrane 6.A spring 150 can be contained within the outer catheter 2 and surroundsthe inner catheter 10. The inner catheter 10 is retracted with theeverting balloon membrane 6 inverted within the outer catheter 2. Aspring stop 148 can be on or otherwise attached to the inner catheter 10and extend radially outward from the inner catheter 10. The spring 150can be compressed in the retracted state by the spring stop 148 againstthe Y-fitting 50 that contains the Touhy-Borst mechanism with theTouhy-Borst gasket 142 to maintain internal pressurization of theeverting catheter system 106. The Touhy-Borst gasket 142 can seal aroundthe inner catheter 10. The spring compression can occur when the innercatheter 10 is placed in the retracted state with the everting balloon22 inverted. The spring 150 can be locked in place by the spring button(also referred to as the release button 146). The spring button canprovide a mechanical restriction to hold the spring stop 148 in placeonce retracted. (The release button 146 can be on the outer catheter 2.The release button 146 can be for releasing the spring 150 and allowingthe inner catheter 10 to advance within the outer catheter 2 andadvancing the balloon membrane 6 in conjunction with balloon pressure.)When the outer portions 144 of the Spring stop 148 are compressed by thephysician, the spring button internal diameter opens and allows thecompressed spring 150 to open and push against the spring stop 148. Thisallows the inner catheter 10 to advance and release the everting balloonmembrane 6. The speed or rate of movement of the inner catheter 10 isgoverned by the resistance caused by friction within the gasket in theY-fitting 50. The rate of movement of the everting balloon 22 should bewithin a speed that allows for easy observation by the physician withultrasound imaging. Too rapid eversion may be clinically unacceptable ormay cause discomfort to the patient. Eversion that is too slow mayprolong the procedure unnecessarily. In numerical terms, the rate ofclinically acceptable inner catheter 10 advancement ranges from 5 to 20seconds for complete eversion of a 5 cm length of balloon. Alternativelyor in combination with the friction within the gasket, the rate ofmovement forward of the inner catheter 10 can be restricted or regulatedby mechanical dampeners (not shown), dash-pots which slow movement,ratchets 190 that control the rate of movement in step-wise movements,or wheels with gearing that slow the rate of movement which can limitthe speed in which the inner catheter 10 advances within the outercatheter 2. In the configurations described above, once the evertingcatheter system 106 is pressurized, the advancement of the innercatheter 10 and everting balloon membrane 6 can occur automatically in aslow fashion, or since the proximal end of the inner catheter 10 isaccessible, the rate of movement can be observed and over-riddendirectly by the physician by manipulating the proximal portion of theinner catheter 162 in conjunction with the automatic advancementmechanism. In the configurations above, energy is stored by a spring 150that is compressed. The force required to move or advance the innercatheter 10 while pressurized, and within a clinically acceptable rateof movement, can be determined by measuring the force and selecting aspring 150 and spring constant that while under compression provides thenecessary force for movement. Alternatively the spring 150 can be woundor rotated to create stored energy.

FIGS. 17B, 17B′, and 17B″ illustrate that the everting catheter system106 can have a spring loaded inner catheter 10 for automaticallyadvancing the inner catheter 162 for the eversion process for thedeposition of reproductive matter in the uterine cavity. The spring 150can be located on the proximal portion of the inner catheter 184. Whenthe inner catheter 10 is fully retracted, energy can be stored in aspring 150 in a fully extended or retracted position. The spring 150 canurge the advancement of the inner catheter 10 when the spring 150 isreleased. The rate or speed of movement of the inner catheter 10 can begoverned or regulated by the friction in the gasket in the Touhy-Borst.In addition, the rate of movement forward of the inner catheter 10 canbe restricted or regulated by mechanical dampeners, dash-pots which slowmovement, ratchets 190 that control the rate of movement in step-wisemovements, or wheels with gearing that slow the rate of movement whichcan limit the speed in which the inner catheter 10 advances within theouter catheter 2.

FIG. 17B illustrates that the system can have a Toughy-Borst Y-fitting142 with an internal gasket. The release button 146 can be depressed toRelease button 146 to allow the inner catheter 10 to advance.

FIG. 17B′ illustrates that the spring 150 can be in its natural,unstressed state when advancement of the inner catheter 10 is completed.At the completion of the eversion process, the release button 146 candisengage to allow the inner catheter 10 to be retracted.

FIG. 17B″ illustrates that once disengaged, the spring 150 remains andallows for the inner catheter 10 to be retracted.

FIGS. 17C, 17C′, and 17C″ illustrate that the everting catheter system106 can have a spring 150 loaded inner catheter 10 for automaticallytranslating and retracting the inner catheter 10. The first and secondscan be located on opposing positions of the inner catheter 10 and byselectively storing energy, and releasing energy of one spring 150, andthen the contralateral spring 150, can create both the advancement andretraction of the inner catheter 10. Both springs 150 can be compressedat the start of the procedure but restrained in the held (e.g.,compressed) position. The everting balloon system 8 can be pressurized.The first spring 166 can be released by actuating the first releasebutton 168 to allow the advancement of the inner catheter 10. Once theeversion process has been completed, the first spring 166 can be nolonger engaged with the spring stop 148. At the completion of theeversion process, the inner catheter 10 can then be positioned for theaction to be created by the second spring 164. After the deposition ofreproductive matter into the uterine cavity, the second spring 164 canbe released by actuating the second release button 170 to retract theinner catheter 10. Concurrent with the advancement and retraction of theeverting catheter system 106, the physician can maintain control of theTUS probe while only requiring the button release of the first andsecond spring 164 for the eversion and inversion process. The system canhave a single release button 146 that can toggle between the twofunctions (releasing the first spring 166 and the second spring 164)mentioned above.

FIG. 17C illustrates that the inner catheter 10 can be retracted at thebeginning of procedure with the everting balloon 22 pressurized. Thefirst spring 166 can be in position and in a compressed state. Thesecond spring 164 can be in position and in a compressed state.

FIG. 17C′ illustrates that inner catheter 10 can be advanced and theballoon can be allowed to evert. The first release button 168 can beactuated. The advance inner catheter 10 can be advanced and thepressurized balloon can be everted.

FIG. 17C″ illustrates that the second release button 170 can beactuated. The inner catheter 10 can retract and the pressurized ballooncan be inverted. After deposition of reproductive matter in the uterinecavity, actuation of the second release button 170 can retract the innercatheter 10 and the balloon can be allowed to invert.

FIG. 17D illustrates an everting catheter system 106 with a motorizedmechanism for the advancement and retraction of the inner catheter 10when the everting balloon membrane 6 is pressurized. The system can havea handle 120 which is holding within itself a Touhy-Borst gasket 142, amotor and battery 178 can be housed with a rotating motor gear wheel180. The motor and battery 178 can be activated by a toggle switch 176connected by a toggle wire 174 which can direct the starting, ending,and direction of the gear wheel. Coupled to the gear wheel can be atraction wheel 182.

The system can have a Rotation Wheel 172 to guide advancement andretraction of the inner catheter 10. The Traction Wheel 182 can beconnected to Motor Gear Wheel 180 for advancement and retraction of theinner catheter 10. The motor gear wheel 180 can be connected to themotor and the battery. The motor and the battery can be connected to atoggle wire 174. The toggle wire 174 can be connected from a toggleswitch 176 to the motor and battery to turn the motor on and off andreverse its direction. The toggle switch 176 can turn the motor on andoff and reverse its direction for the advancement and retraction ofinner catheter 10.

The everting balloon membrane 6 can be connected to the inner catheter10 distal end.

The traction wheel 182 can engage the inner catheter 10 forautomatically translating and retracting the inner catheter 10. A guidewheel can secure the contact of the inner catheter 10 to the tractionwheel 182. Once the everting balloon membrane 6 is pressurized, aforward push on the toggle switch 176 can activate the motor and battery178 to advance the gear wheel to rotate the traction wheel 182. Once thedeposition of reproductive matter to the uterine cavity is completed,the toggle switch 176 can be pushed in the opposite or backwarddirection to initiate retraction of the inner catheter 10.

FIGS. 18A through 18E illustrate speculums and their mechanisms foropening the vagina for the insertion of devices for transvaginalprocedures. Vaginal speculums are designed to expose the cervix 202 sothat the physician can directly visualize the exocervix.

FIG. 18A illustrates a standard bi-valved, two blade (duckbill) vaginalspeculum with anterior and posterior wall opening mechanism.

FIG. 18B illustrates a cervix 202 with a standard vaginal speculum withan anterior and posterior wall opening mechanism. Also shown is thecircumferential housing of a bi-valved vaginal speculum.

FIG. 18C illustrates a lateral wall opening speculum.

FIG. 18D illustrates a Sims speculum having a single arm for opening theposterior or anterior wall.

FIG. 18E illustrates a 4-way (4 blades) opening speculum with anterior,posterior, and lateral wall opening blades.

The most common vaginal speculums have arms or blades 186 for displacingthe anterior and posterior walls of the vagina. The standard vaginalspeculum is bi-valved with two blades 186 and has a duckbill appearance.These vaginal speculums come in multiple sizes and lengths withratcheting mechanisms to maintain the opening of the vagina 200. Somevaginal speculums have a continuous circumferential housing to containthe mechanism for opening or separating the blades 186 and applyingpressure on the anterior and posterior walls of the vagina. Somespeculums have a side-opening housing that allows the speculum to beslipped out of the vagina while allowing the devices to remain in place.In practice, IVF specialists need to remove the vaginal speculum toeffectively operate the TUS probe which becomes increasingly difficultwith embryo transfer catheter 28 systems that require two hands foreffective operation. Alternatively Sims speculums, or single arm orsingle blade 186 speculums, have a separate posterior arm component thathas a separate anterior arm component for opening the vagina. The Simsspeculum used in the posterior aspect of the vagina can be insertedsideways to minimize the insertion profile. Secondarily, the arm can berotated so that the flat portion of the Sims speculum arm is horizontalto the vaginal opening to thereby open the bottom portion of the vagina.The flat arm provides pressure on posterior vaginal opening andconversely, an anterior Sims speculum or single-arm speculum willprovide pressure on the anterior opening of the vagina 200. When usingSims speculum arms on both the anterior and posterior walls, thisrequires two physicians or operators and the arms can be slipped outseparately to allow for devices to remain in place in the vagina.Another type of vaginal speculums are designed to open only the lateralwalls of the vagina as opposed to the anterior and posterior walls ofthe vagina. Yet another type of vaginal speculum contains four arms thatopens the anterior, posterior, and both lateral walls of the vagina. Inaddition, some speculums are configured with 3 blades. For all of thesevaginal speculums, they are designed to open the vagina to providevisual and manual access to the cervix 202 for transvaginal procedures.

For clinical practice, the IVF specialist will wash the exocervix priorto the insertion of the embryo transfer catheter 28 system. Besidesclearly visualizing the cervical opening, the IVF specialist does notwant vaginal fluids or bacteria on the cervix 202 or within the vaginato come into contact with the embryo transfer catheter 28 system duringthe insertion of catheters within the endocervix and then the uterinecavity. An additional purpose of the vaginal speculum is to keep tissuesfrom the vaginal walls away from the cervix 202 so that the embryotransfer catheter 28 system does not come into contact with the labia orinner vaginal walls during the insertion process. The size and physicalpresence of the vaginal speculum does not facilitate the insertion andoperation of a TUS probe in combination with standard embryo transfercatheter 28 systems that require multiple hands to effectively operate.In particular, TUS probes are designed to be placed at back wall of thevagina at the anterior fornix next alongside the cervix 202. Andfurther, it has been reported in medical literature that the physicalmanipulation of the vaginal speculum can incite uterine contractionswhich are not desirable for IVF procedures which require theimplantation of embryos. In addition, female patients have reporteddiscomfort with the manipulation of vaginal speculums in the process ofretracting the vaginal walls to expose the cervix 202. Using smaller,lower profile vaginal speculums or pediatric speculums would be morecomfortable for the patient and reduced physical size and reducedvaginal manipulations will thereby lower the incidence of subsequentuterine contractions. Unfortunately the operation of existing embryotransfer catheter 28 systems require two hands and necessitate greatervaginal openings. As well as room to avoid inadvertent contact with thevaginal walls during the catheter insertion process.

Use of Sims single-arm speculums and flat arms on outermost opening ofthe vagina 200 provoke pressure on the posterior or anterior openings ofthe vagina. To summarize, a vaginal speculums that are designed tofunction with a lower profile and can be used in conjunction with anembryo transfer catheter 28 system would be a benefit.

FIGS. 19A to 19D illustrate a speculum system that can be suited forworking with the everting catheter system 106. The speculum can bedesigned for positioning at the posterior aspect of the vaginal openingwith angled walls that fan open. The configuration of the speculum canminimize radial pressure on the vaginal walls and provide enough openingspace to visualize the cervix 202 and/or insert a TUS probe. Theeverting catheter system 106 can be operated with one hand. The evertingcatheter system 106 can have the components that contact the endocervixand uterine cavity within the delivery catheter 32, for example to avoidcontamination by touching the vaginal walls and to minimize the need formaking a large vaginal opening (e.g., as with a standard speculum).

FIGS. 19A and 19A′ illustrate the operation of the speculum in an axialview looking from the proximal end of the speculum. As shown in FIG.19A, the two blades of the speculum can be nested in each other duringthe insertion process. Manipulation (e.g., squeezing together orrotation toward the other side) of the handle 120 can open the blades atthe lowest, posterior point to the angle desired by the physician. Thehandle 120 can have a ratchet 190 mechanism to lock the blades at adesired angle in the open position. The contralateral blades and handlescan rotate about an axis point 188 (also referred to as the central axis216), such as a pin 138 or pivot.

FIG. 19B illustrates the speculum in a side view with the handlessqueezed together. The speculum can have a speculum distal end 194. Theblades 186 can each have a larger proximal projection 196 and a smallerdistal projection 192. The projections can be curved. The largerprojections of the blades 186 can be directed towards the exteriorportion of the vagina. The larger proximal projections 196 can open theexterior portion of the vagina at the posterior angle created by thecentral axis 216 point of the speculum. The smaller distal projection192 can be placed near the cervix 202 and can allow for greater room forplacement of the TUS probe. The axis point 188 can be a central axis 216and can form a posterior angle between the blades 186 and the portion ofthe speculum proximal to the axis point 188.

FIG. 19C illustrates the speculum in a diagrammatic format depicting theopening of the vagina 200 with a placement of a TUS probe in closeproximity to the cervix 202 and the exocervial os 204 (the opening ofthe cervix 202). The left and right blades 186 can be opened to holdopen the vagina and provide access to the cervix 202 and exocervial os204 for visual inspection and/or placement of the TUS probe. The blades186 can be angled, for example, toward the patient's right side to fitthe TUS probe on the right side of the cervix 202. (During typical use,the left blade 208 will be on the patient's right side and the rightblade 206 will be on the patient's left side.)

FIG. 19D illustrates the speculum in a diagrammatical view with the leftblade 208 (fits on the patient's right hand side) that can have asmaller projection (i.e., height) than the right blade 206. The smallerleft blade 208 can allow for greater room for the TUS probe when handledby the physician's left hand (e.g., leaving the right hand of thephysician to operate the everting catheter system 106). The larger andsmaller projections of the blades 186 can be reversed laterally or alongthe length, for example, if the physician prefers to use the right hadfor control of the TUS probe.

FIGS. 20 and 20′ illustrate the speculum with a speculum couplingmechanism 212 for an everting catheter system 106. Within the anteriorsurface of the central axis 216 of the speculum can be a couplingmechanism to place and/or attach to the everting catheter system 106.The coupling mechanism can allow the IVF specialist to place theeverting catheter system 106 so that the position of the evertingcatheter 218 is maintained, allowing the physician to use his/her handsfor advancing the embryo transfer catheter 28 and TUS probe.

FIGS. 21 and 21′ illustrate that an acorn tip 110 at the distal end ofthe everting catheter 218 can be malleable or articulatable, forexample, to allow the distal end opening of the everting catheter system106 to be directed towards the exocervix os (opening of the cervix 202).In the malleable tip design shown in FIG. 21, a deformable spring coil220 can be bendable and hold the curve made on the distal end of theeverting catheter 218 to direct the acorn tip 110 towards the opening ofthe cervix 202. A stainless steel mandrel can be supplied within theouter catheter 2 that can allow the physician to place a bend within thedistal end of the catheter to direct the distal end opening towards theexocervical os 204.

FIG. 21′ illustrates that the articulating distal end can have a pullwire 222 within the everting catheter 218 that can be configured to bepulled to change the angle of the tip and direct the distal end openingtowards the exocervical ox of the patient. At the proximal end of theeverting catheter 218, the physician can actuate, manipulate, or pullthe pull wire 222 to bend the acorn tip 110 selectively. The evertingcatheter 218 can have multiple pull wires 222 located at differentangles around the catheter to control the angle of the acorn tip 110 inmultiple directions.

FIG. 22A illustrates that the distal end of an everting catheter 218 canhave an acorn tip 110 that is detachable from the remainder of theeverting catheter 218. The acorn tip 110 can have a soft, rounded tip.

FIG. 22A′ illustrates the variation of the distal end of an evertingcatheter of FIG. 22A with the acorn tip 110 removed to reveal apenetrating tip 226 or member for insertion into the exocervical os 204.The penetrating tip 226 can be designed to penetrate slightly theexocervix os to allow entry of the everting balloon 22 into theendocervical canal. The outer surface of the catheter can havemechanical detents 224 that can be radially retractable and snap-fit orinterference fit the radially inner surface of the acorn tip 110. Theacorn tip 110 can be detachably connected to the mechanical detents 224.

FIG. 22B illustrates that the distal end of the everting catheter canhave a retractable acorn tip 110. The outer surface of the catheter canhave threads 228 that can helically engage matching threads 228 on theinner surface of the acorn tip 110.

FIG. 22B′ illustrates that the acorn tip 110 can be rotated with respectto the everting catheter 218, causing the acorn tip 110 to helicallyproximally retract with respect to the everting catheter 218. Forexample, the acorn tip 110 can be pressed into and braced against thewall around the cervical entrance 38 at the end of the vagina while theeverting catheter 218 is rotated. The same backward or rearwardrepositioning of the acorn tip 110 can occur by directly pushing theacorn tip 110 backward on the outer catheter 2. After the acorn tip 110can be sufficiently retracted to reveal the penetrating tip 226 ormember at the distal terminal end of the everting catheter 218. Thepenetrating tip 226 can insert into the exocervical os 204.

FIGS. 23 and 23′ illustrate that the controller 118 that can advance andretract both the inner catheter 10 and the embryo transfer catheter 28can have controller wheels 230 or gears 232. The controller wheels 230can engage the inner catheter 10 for the entire advancement until theinner catheter 10 abuts the Y-fitting 50 of the everting catheter system106. The controller wheels 230 can be spring-loaded, for example, toallow the controller wheels 230 to expand apart or enlarge (whenanalyzed as a single component together), as shown by arrows in FIG. 23,and allow the proximal luer hub to pass through the wheels and stop atthe completion of the eversion process. At the point in the IVFprocedure, the embryo transfer catheter 28 can be passed through thecentral lumen of the inner catheter 10 and into the uterine cavity. Thecontroller wheels 230 can be configured to engage the distal end of theembryo transfer catheter 28, or in the case of an embryo transfercatheter 28 with a proximal portion with a larger outer diameter, thecontroller wheels 230 can engage the larger outer diameter portion. Thecontroller wheels 230 can then advance and retract the embryo transfercatheter 28.

FIG. 23 illustrates that the controller 118 wheels can be spring-loadedto expand and contract to accommodate the varying outer diameters of theinner catheter 10, hub, and embryo transfer catheter 28, for example assome or all of the elements pass between the controller 118 wheels.

FIG. 23′ illustrates that the controller 118 wheels can expand thenre-coil due to spring loading for advancing and retracting the embryotransfer catheter 28.

U.S. Provisional Application Nos. 61/902,742, filed Nov. 11, 2013,61/977,478, filed Apr. 9, 2014; 62/005,355, filed May 30, 2014,62/007,339, filed Jun. 3, 2014, 62/528,422, filed Jul. 3, 2017, and62/553,057, filed Aug. 31, 2017; U.S. patent application Ser. No.16/029,305, filed Jul. 6, 2018; International Patent Application No.PCT/US18/49234, filed Aug. 31, 2018; and U.S. Pat. No. 9,028,401, issuedMay 12, 2015 and U.S. Pat. No. 10,034,986, issued Jul. 31, 2018, areincorporated by reference herein in their entireties, and any elementsdescribed therein can be used in combination with any of the elements inthis application.

Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one). Any species elementof a genus element can have the characteristics or elements of any otherspecies element of that genus. The media delivered herein can be any ofthe fluids 70 (e.g., liquid, gas, or combinations thereof) describedherein. The patents and patent applications cited herein are allincorporated by reference herein in their entireties. Some elements maybe absent from individual figures for reasons of illustrative clarity.The above-described configurations, elements or complete assemblies andmethods and their elements for carrying out the disclosure, andvariations of aspects of the disclosure can be combined and modifiedwith each other in any combination. All devices, apparatuses, systems,and methods described herein can be used for medical (e.g., diagnostic,therapeutic or rehabilitative) or non-medical purposes.

We claim:
 1. A method for delivering matter into a uterine cavitycomprising: positioning an everting balloon system adjacent to acervical canal, wherein the everting balloon device comprises a firstcatheter and an everting balloon attached to the first catheter, andwherein the first catheter has a catheter lumen and a distal port at thedistal end of the catheter lumen, and a delivery catheter attached toopposite end of the everting balloon from the first catheter; evertingthe everting balloon in the cervical canal, wherein the evertingcomprises pulling the first catheter distally through the cervicalcanal, wherein the first catheter has a fixed alignment with thedelivery catheter and everting balloon, the and wherein the evertingcomprises inflating the balloon distal to the first catheter.
 2. Themethod of claim 1, wherein the fixed alignment prevents twisting of theeverting balloon during the eversion and inversion process.
 3. Themethod of claim 2, wherein the fixed alignment prevents over extensionof the everting balloon during the inversion process.
 4. A method fordelivering matter into a uterine cavity comprising: everting a balloonin a cervical canal, wherein the balloon is attached to a firstcatheter, and wherein everting comprises pulling the first catheterdistally through the cervical canal; transporting a flexible tipguidance wire through the first catheter into the uterine cavity todirect the distal end of the everting balloon towards a targeted region;transporting an catheter of the reproductive material once access to thetargeted region is reached.
 5. A method for delivering matter into auterine cavity comprising: everting a balloon in a cervical canal,wherein the balloon is attached to a first catheter, and whereineverting comprises pulling the first catheter distally through thecervical canal; pressurizing balloon system with complaint member tofacilitate keeping internal pressure within an operating range.
 6. Amethod for delivering matter into a uterine cavity comprising: evertinga balloon in a cervical canal, wherein the balloon is attached to afirst catheter, and wherein everting comprises pulling the firstcatheter within a delivery catheter and distally through the cervicalcanal; and distal end of delivery catheter can adjust the working lengthof the everting balloon.
 7. A system for delivering matter into thereproductive tract of a female comprising: a first catheter having alumen and a distal lumen port, wherein the first catheter has aretracted configuration and an extended configuration; an evertingballoon attached to the first catheter, wherein at least a length of theeverting balloon extends past the distal end of the first catheter whenthe first catheter is in the extended configuration; a second catheterslidably located in the first catheter; and second catheter comprises analignment piece to prevent rotation of the second catheter in relationto the first catheter.
 8. The system of claim 7, further comprising astopping piece to prevent over extension of the everting balloon whenthe second catheter is retracted in the first catheter during inversionof the everting balloon.
 9. A method for delivering matter into auterine cavity comprising: positioning an everting balloon systemadjacent to a cervical canal, wherein the everting balloon devicecomprises a first catheter and an everting balloon attached to the firstcatheter, and wherein the first catheter has a catheter lumen and adistal port at the distal end of the catheter lumen, and a deliverycatheter attached to opposite end of the everting balloon from the firstcatheter; everting the everting balloon in the cervical canal, whereinthe everting comprises pulling the first catheter distally through thecervical canal, wherein the first catheter has an attachment forcoupling the first catheter to a transvaginal ultrasound probe, the andwherein the everting comprises inflating the balloon distal to the firstcatheter.
 10. The method of claim 9, wherein the attachment for couplingthe first catheter to the transvaginal probe maintains the position ofthe everting balloon system during the eversion and inversion process.11. The method of claim 10, wherein the attachment for coupling thefirst catheter to the transvaginal probe maintains the position of theeverting balloon during the process of inserting a transfer catheterwithin the everting balloon system for delivering matter into theuterine cavity.
 12. A method for delivering matter into a uterine cavitycomprising: everting a balloon in a cervical canal, wherein the balloonis attached to a first catheter, and wherein everting comprises pullingthe first catheter distally through the cervical canal; pressurizing theballoon; placing stored energy to act on the first catheter; and whereinthe advancement of the balloon is performed by a stored energy appliedto the first catheter in combination with the pressurization of theballoon; and advancement of the first catheter is initiated by releasingthe stored energy connected to the first catheter.
 13. A method fordelivering matter into a uterine cavity comprising: an everting cathetersystem with an everting a balloon in a cervical canal, wherein theballoon is attached to a first catheter, and wherein everting comprisespulling the first catheter distally through the cervical canal; applyinga rotationally opening speculum with coupling mechanism; attachingeverting catheter system to the speculum using coupling mechanism.
 14. Amethod for delivering matter into a uterine cavity comprising: evertinga balloon in a cervical canal, wherein the balloon is attached to afirst catheter, and wherein everting comprises pulling the firstcatheter within a delivery catheter and distally through the cervicalcanal; and an acorn tip at the distal end of delivery catheter canadjust from a soft rounded profile to a penetrating distal tip profile.